Trial · NCT02819635
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | At Week 8 | SS1 main population (ITT1A): those randomized to ≥1 dose of study drug during the initial part of SS1. Non-responder imputation (NRI) was used to impute missing values. | percentage of participants | NUMBER |
| PRIMARY | Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | At Week 8 | SS2, Part 1 population (ITT1): all randomized participants in the 8-week double-blind induction period who received ≥1 dose of study drug. NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used for SS2, with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| PRIMARY | Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52 | At Week 52 | Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2 | At Week 2 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Change in Full Mayo Score From Baseline to Week 8 | Baseline (Week 0), Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Last observation carried forward (LOCF) was used for missing data. | units on a scale | MEAN |
| SECONDARY | Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2 | At Week 2 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8 | Baseline (Week 0), Week 8 | The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8 | At Week 8 | The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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